Cleared Traditional

K812506 - THE ARTHROFILE

K812506 is an FDA 510(k) clearance for THE ARTHROFILE, manufactured by Dyonics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTR cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812506 · Dyonics, Inc. · General & Plastic Surgery device
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Sep 1981
Decision
23d
Days
Class 1
Risk

K812506 is an FDA 510(k) clearance for the THE ARTHROFILE. Classified as Rasp (product code HTR), Class I - General Controls.

Submitted by Dyonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dyonics, Inc. devices

FDA 510(k) Submission Details - K812506

510(k) Number K812506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1981
Decision Date September 24, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

HTR Device Classification - Class 1, General Controls

Product Code HTR Rasp
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HTR Rasp

All 8
Devices cleared under the same product code (HTR) and FDA review panel - the closest regulatory comparables to K812506.
BIODYNAMICS SMALL JOINT BRUSH #1203
K870333 · Biodynamic Technologies, Inc. · Feb 1987
BIODYNAMICS FEMORAL CANAL BRUSH #1201
K870349 · Biodynamic Technologies, Inc. · Feb 1987
RICHARDS ACETABULAR BRUSH
K813093 · Richard'S Medical Equip., Inc. · Nov 1981
MICRO RASPS
K780771 · Amsco Co. · May 1978
INTERMEDULLARY BRUSH
K771016 · Howmedica Corp. · Jan 1978
RASPS FOR SCRAPING BONE
K771745 · Depuy, Inc. · Sep 1977